Endotoxin Analysis Systems

FUJIFILM Wako provides analysis systems with software that is user friendly and capable of performing all methodologies for LAL testing.

• Toximaster® software: FDA 21 CFR Part 11 ERES compliant, Endotoxin determination in compliance with pharmacopoeias (USP/EP/JP) for BET
• Capable of creating three types of curves: internal standard curve, manual input curve and a measured curve, Product endotoxin limit and MVD generation, Allows trending of product results over time and early detection of potential product failures, Generates hard copy printouts with all pertinent information for routine audits through three unique audit trails, Creation of a standard workflow to be reviewed, confirmed and approved prior to operating, Security functions to lock the application, disable an account and lock out the system, Backup of the user management database and automatic backup of the system information database, Improved precision and accuracy over the traditional gel clot method, Ideal software for comparative testing and validating most LAL

Toxinometer® System: Single assay module can simultaneously measure up to 16 samples, Expansion modules are available (up to 8) to extend the number of samples in multiples of 16, Single-test configuration avoids the 'hot wells' phenomenon associated with microplate eaders by evenly distributing thetemperature in all single wells, Reduces the chance of contamination due to the single-well formats, Ideal for users who are converting from gel clot method to kinetic turbidimetric assays.

CMD aBET™: Portable and fully integrated bench top system with FDA 21 CFR Part 11 compliant software, Data back up to PC by binary code, preventing the ability of data modification, Backups made in two formats-native firmware and HTML for ease of viewing records, 7-inch Touchscreen, QR Code access cards included (1 administrator card, 10 user cards), Run times of no more than 30 minutes per assay can achieve 0.001EU/ml, Uses less reagent than traditional methods, Minimal user input needed beyond addition of sample, Guided steps for performing various assays, Compatible with color and opaque samples, For use with PYROSTAR™ ES-F 0.015EU/ml reagent available in single test, 20 test, and 50 test vials.

IQ/OQ, Maintenance, Warranty and User Training packages available.